A study to define the platelet count below which critically ill patients should receive a platelet transfusion before an invasive procedure

Not Applicable

• Conditions: Critical care; Not Applicable

• Registration Number: ISRCTN79371664
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-30
• Last Update Posted: 18 June 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2550

Inclusion Criteria

Current participant inclusion criteria as of 17/03/2023:
1. Adult (aged 18 years or older)
2. Accepted for admission or admitted to a participating critical care unit
3. Platelet count <50 x 10e9/l
4. Planned to undergo a specified* low bleeding risk invasive procedure OR platelet transfusion being considered for an 'other' procedure

*Specified low bleeding risk invasive procedures include the following:
1. Central venous vascular catheter insertion (including vascular access for renal replacement therapy)
2. Paracentesis/superficial abdominal fluid collection drainage
3. Pleural aspiration

‘Other’ procedures may be included if the clinician deems these to be a low bleeding risk invasive procedure and a platelet transfusion is being considered for the procedure. These include, but are not limited to, the following:
1. Arterial catheter insertion
2. Arterial or central venous catheter removal
3. Pleural drain
4. Interventional radiology (as defined by Society of Interventional Radiology guidelines)
5. Bronchoscopy with or without lavage
6. Wound dressing changes
7. Surgical procedures where the clinical team agree the risk of bleeding is low, e.g. re-look laparotomy, or wound closure

Previous participant inclusion criteria:
1. Adult (aged 18 years or older)
2. Accepted for admission or admitted to a participating critical care unit
3. Platelet count <50 x 10e9/l
4. Platelet transfusion being considered for a low bleeding risk invasive procedure*

*Low bleeding risk invasive procedures include the following:
1. Vascular catheter insertion and removal (central venous – including vascular access for renal replacement therapy)
2. Paracentesis/superficial abdominal fluid collection drainage
3. Pleural aspiration

‘Other’ procedures may be included if the clinician deems these to be a low bleeding risk invasive procedure. These include, but are not limited to, the following:
1. Arterial catheter line insertion
2. Pleural drain
3. Interventional radiology (as defined by Society of Interventional Radiology guidelines)
4. Bronchoscopy with or without lavage
5. Wound dressing changes
6. Surgical procedures where the clinical team agree risk of bleeding is low, e.g. re-look laparotomy, or wound closure

Exclusion Criteria

Current participant exclusion criteria as of 17/03/2023:
1. Ongoing major haemorrhage requiring blood products and/or surgical/radiological intervention*
2. Intercranial haemorrhage within prior 72 hours*
3. Contra-indication to platelet transfusion (such as thrombotic microangiopathies; heparin-induced thrombocytopaenia; immune thrombocytopaenia; congenital platelet function defects)
4. Acute promyelocytic leukaemia (APML)
5. Known advance decision refusing blood/blood component transfusions (e.g. Jehovah’s Witnesses)
6. Death perceived as imminent or admission for palliation
7. Previously randomised into T4P
8. Fulfilled all the inclusion criteria and none of the other exclusion criteria =72 hours

*Exclusion criteria no. 1 and 2 are dynamic, and if resolved, the patient may be reconsidered for
the trial

Previous participant exclusion criteria:
1. Ongoing major haemorrhage requiring blood products and/or surgical/radiological intervention*
2. Intercranial haemorrhage within prior 72 hours*
3. Contra-indication to platelet transfusion (such as thrombotic microangiopathies; heparin-induced thrombocytopaenia; immune thrombocytopaenia; congenital platelet function defects)
4. Advance decision refusing blood/blood component transfusions (e.g. Jehovah’s Witnesses)
5. Death perceived as imminent or admission for palliation
6. Previously randomised into T4P
7. Fulfilled all the inclusion criteria and none of the other exclusion criteria =72 hours

*Exclusion criteria no. 1 and 2 are dynamic, and if resolved, the patient may be reconsidered for the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified